1. Hot Topics in Pharmacy Purchasing: Regulatory Requirements, New Drugs, and GS1 Initiative Lyle Matthews, Pharm.D, MAM Director, Pharmacy Services Eisenhower Medical Center

2. Goals Describe the three most challenging regulatory requirements of regulatory agencies and State Boards of Pharmacy involving Pharmacy Purchasing Professionals today.

3. Goals (cont.) List the three most interesting new medications coming in late 2011 and 2012. Describe what the GS1 or Serial NDC number initiative is and what it means to Pharmacy Purchasing Professionals

4. Disclaimers One Directors Thoughts (Mine) Each Organization is Different General Ideas And Philosophies Goal is to present concepts that can be related to your individual health systems

5. Regulatory Challenges Facing Pharmacy Purchasing Professionals What are the Issues? Who is responsible for them? How do we comply? Without losing our minds Without losing our friends

6. Regulatory Agencies Joint Commission on Accreditation of Healthcare Organizations Centers for Medicare & Medicaid Services State Boards of Pharmacy State Departments of Public Health Drug Enforcement Administration Food and Drug Administration

7. What are the Regulatory Issues Involving Medications? OrderingReceivingDeliveryStorageSecurityAccessControlMonitoring Record Retention

8. Ordering and Receiving Who can Order? Do you Reconcile Receipt? Controlled Substances Are There Any Openings in System?

9. Delivery Licensed Personnel? Volunteers or Transport Staff? OnsiteOffsite Any process for security and control? Reconciliation

10. Storage Refrigerate or not? Monitoring of Temps. Vaccines, Vaccines, Vaccines Sound Alike - Look Alike (SALA) Functional Separation Floor Stock Crash Carts & Emergency Boxes

11. Security Medication Rooms Automated Dispensing Cabinets (ADCs) Lockable Cabinets Lockable Refrigerators Controlled Substances

12. Access Who has access to our Meds? Seemingly Everyone Seemingly Everyone Who controls who has Access to: Medication Rooms? Medication Rooms? ADCs? ADCs? Controlled Substance Room? Controlled Substance Room?

13. Control Who can change things without you knowing? Hospital Formulary Automated Dispensing Cabinets –PAR levels –Locations

14. Answer to Question: Who Can Change Things? Seemingly Everyone Seemingly Constantly Seemingly Forever

15. Monitoring Who is watching? Is anything Missing? Has Anything Changed? Controlled Substance Ordering Patterns

16. Record Retention Recalls Trailer Theft Invoices (3 years on site?) Controlled Substances Invoices 222 Forms CSOS

17. Who is Responsible For Helping Control Things? Director of Pharmacy? Operations Manager? Technician Supervisor? Nursing Staff? O.R. and E.D. Staff? Everyone

18. Sound Familiar? I dont know how the vaccines are stored, ask the Buyer. I dont know what temperature the refrigerators are supposed to be kept, ask the Buyer. I dont know who has access to the Automated Dispensing Cabinets, ask the Buyer.

19. How Do We Control These Challenges Communicate With The Pharmacy Management Team Ensure They Realize You Have to Know What is Happening Ensure You are Included In all Discussions P&T Committee Membership?

20. Regulatory Summary Everyone is responsible for Regulatory Compliance Everyone Has Their hands in Our Meds – Try to control them. Communicate and Solve Problems Together As a Team

21. Joint Commission Survey Aug. 9-12, 2011 Magnesium Sulfate Recalls –Notification of Nursing/Medical Staffs Expired and Recalled Medication Storage – Segregation Are you a County/State Cache Site?

22. New Medications for 2011 and 2012 Some have Financial Impact Some have Clinical Impact Some will just have Psychological Impact on Us and Make Our Lives Difficult

23. Pradaxa (dabigatran etexilate mesylate) Highly Controversial Expensive compared to Coumadin BID dosing (vs. daily Coumadin) Leap of faith for patients who are used to having INRs drawn Reports of Bleeding

24. Effient (prasugrel) Oral Antiplatelet Medication for patients following angioplasty No proven reversal agent Cardiac Surgeons are largely opposed and/or skeptical

25. Provenge (Sipuleucel-T) For Advanced Prostate Cancer FDA Approved April 2010 Very complicated administration $93,000 for course of Treatment Controversial – extends life by approximately 4.5 months All sorts of problems for Dendreon

26. Xarelto (rivaroxaban) DVT prophylaxis in knee and hip replacement patients FDA Approved July 1, 2011 Marketed against Lovenox/Coumadin Taken orally (10mg daily) Applying for indication for A-fib pts. Available in Europe since 2008

27. Arcapta Neohaler (indacaterol) Long acting beta-2 adrenergic agonist for COPD patients 75 mcg capsule daily using the Neohaler Not for asthma patients Will be available in 1 st quarter of 2012

28. Brilinta (ticagrelor) FDA Approved July 2011 $7.24 per day (20% more than Plavix (clopidogrel) Shown superior to Plavix when combined with low dose aspirin to prevent heart attacks and strokes clopidogrel generic in May 2012.

29. Yervoy (ipilimumab) Unresectable or Metastatic Melanoma Dose is 3mg/kg IV over 90 min. every 3 weeks x 4 doses 50 mg and 200 mg vials Extends life avg. of 4 months $120,000 for 4 dose course

30. Victoza (liraglutide) For Type 2 Diabetes GLP-1 analog Targeting Pancreatic beta cells Increases Insulin Secretion and move sugar into cells Watch for hints of weight loss help

31. Dificid (fidaxomicin) Already Released For Clostridium dificile associated diarrhea One 200mg tablet BID x 10 days $140 per tablet More expensive that oral Vanco –(less that IV Vanco given orally)

32. Avastin (bevacizumab) Not new Very Expensive and Very Popular Controversial indication for Breast Cancer Keep watching – Changes are Coming

33. Expiring Patents in 2011 LipitorZyprexaLevaquinConcertaProtonix Total sales of $10 Billion in 2010

34. Lipitor (atorvastatin) Patent expired June 2011 Ranbaxy Generic Atorvastatin available Nov. 2011 Significant potential cost savings, but probably further down the road Guess what Pfizer has proposed?

35. GS1 Initiative GS1 or Serial NDC Number Project Guidance for Securing the Drug Supply Chain – Standardized Numerical Identification for Prescription Drug Packages

36. Who are GS1? GS1 is a global organization dedicated to the design and implementation of global standards and solutions to improve efficiency and visibility in supply and demand chains. –From GS1 letter to the FDA April, 2009

37. What does it mean to us? Their goal is to standardize NDC standards globally This would potentially enhance supply chain tracking and tracing Could embed product specific information

38. Thank you for having me again. Best wishes to the NPPA and all of the Pharmacy Purchasing Professionals Questions?